DIRECTOR, DRUG SAFETY & PHARMACOVIGILANCE
Tanner and Associates is recruiting for a Director of Drug Safety and Pharmacovigilance for a leading company located in the NE. The company is engaged in the discovery, development, and commercialization of products for the treatment of various pulmonary diseases.
JOB DESCRIPTION
- Candidate will be responsible for planning, developing, and managing drug safety and pharmacovigilance processes for therapeutics involving investigational and post-marketing drug studies.
- Functions include the collection, evaluation, and communication of safety information, pharmacovigilance, and safety support for clinical trials.
- Candidate will work with vendors to ensure compliance with national and international regulations and requirements.
- Pharmacovigilance activities related to the company’s marketed product are primarily conducted by its marketing partner.
- Candidate will ensure that the company follows appropriate internal processes regarding communication of safety information to its partner.
- Candidate will serve as the primary point of contact with the company’s business partners and will provide internal safety support for the R&D and marketing teams.
RESPONSIBILITIES
- Responsible for ensuring that worldwide Adverse Drug Reporting System adequately captures safety data.
- Ensures the clinical safety of clinical trial studies meet required company and regulatory requirements.
- Evaluates adverse event safety reports and provides ongoing communication between Clinical and Global Safety.
- Maintains the Safety Management Plan/Operating Agreement between the company and the external Safety Vendors.
- Oversees the Drug Safety processes performed by vendors to ensure accuracy, medical appropriateness, and timely delivery of safety data.
- Evaluates vendor SOPs and determines vendor compliance with SOPs, ICH/GCP, and applicable regulations.
- Assists in developing audit plans of company vendors, internal safety, and pharmacovigilance operations, and ensuring that any findings from audits are properly addressed.
- Accountable for budgeting, headcount, outsourcing strategy, and management of a quality pharmacovigilance system to ensure proper risk management of company products are in compliance with all international regulations and guidelines.
QUALIFICATIONS
- Requires M.D. with advanced training in Internal Medicine. Additional training in Pulmonary/Critical Care medicine or Cardiology is a strong plus.
- Board certification/eligibility in a medical discipline.
- 5 years industry experience in biopharmaceutical research and development or with a CRO.
- At least 3 years experience in Drug Safety and Pharmacovigilance.
- Strong knowledge of applicable laws, regulations, guidelines, and best practices.
- Working knowledge of case processing, signal detection, regulatory reporting process, and workflow.
- Working knowledge of MedDRA coding and terminology.
- Experience managing CROs and other contractors.
- Experience should include investigational and post-marketing studies with proficiency in Drug Safety processes, Adverse Event Reporting, Risk Management, and Signal Detection.
- Experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans.
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